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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

New Warnings For Tarceva

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According to the FDA, the cancer drug Tarceva will soon get new warnings added to its label. Tarceva is made by Genentech Inc. and OSI Pharmaceuticals Inc. Physicians were notified of these label changes in April, but the "dear doctor" letter sent by the companies was only recently made public by the FDA. Tarceva monotherapy is used to treat locally advanced or metastic non-small cell lung cancer, after other chemotherapy treatments have failed. When Tarceva is combined with gemcitabine hydrochloride, it is a first-line treatment for locally advanced, unresectable or metastatic pancreatic cancer. Reports of gastrointestinal problems and skin reactions will be included on the new labels for Tarceva. Some of the serious problems linked to Tarceva include gastrointestinal perforation, exfoliative skin conditions, and corneal ulcers. There are also suggestions of Stevens-Johnson syndrome and toxic epidermal necrolysis. Some of the reported cases involved patient deaths.